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The Distribution of Configuration Settings of Medical Devices for Clinical Trials

IP.com Disclosure Number: IPCOM000099116D
Published in the IP.com Journal: Volume 5 Issue 4 (2005-04-16)
Included in the Prior Art Database: 2005-Apr-16
Document File: 2 page(s) / 32K

Publishing Venue

Siemens

Related People

Juergen Carstens: CONTACT

Abstract

The possibilities for the configuration of medical devices (signal recording, imaging, etc.) are increasing along with their complexity. This allows for maximum adaptability to the needs of physicians (radiologists, etc.). The individual experience influences the configuration of the medical device. This results in a large variety of configurations of medical devices used by different physicians/users of the medical devices. Clinical trials rely on standardized data acquisition in order to achieve comparable results. In the case of multicentric trials various sites have different medical devices. The quality of a clinical trial relies on the exact same data acquisition process of which the configuration of the medical device plays a substantial role. Up to now, in clinical trials with more then one site involved and with the requirement for using a medical device for data acquisition it is very likely that the medical devices are configured differently. They might be from the same or from different vendors. Representatives of the various sites - typically investigators and/or users of the medical devices (radiologists, etc.) get together and discuss about the required data for the clinical trial. In a next step they have to translate these requirements into configurations specific to their medical devices. This results in differences of the configurations. The data from the medical devices is comparable based on the experience and the judgement of the users of the medical devices.

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The Distribution of Configuration Settings of Medical Devices for Clinical Trials

Idea: Dr. Ali-Nejat Bengi, DE-Erlangen; Norbert Rahn, DE Forchheim; Markus Schmidt, DE- Erlangen; Horst Schreiner, DE-Erlangen; Dr. Gudrun Zahlmann, DE-Erlangen

The possibilities for the configuration of medical devices (signal recording, imaging, etc.) are increasing along with their complexity. This allows for maximum adaptability to the needs of physicians (radiologists, etc.). The individual experience influences the configuration of the medical device. This results in a large variety of configurations of medical devices used by different physicians/users of the medical devices.

Clinical trials rely on standardized data acquisition in order to achieve comparable results. In the case of multicentric trials various sites have different medical devices. The quality of a clinical trial relies on the exact same data acquisition process of which the configuration of the medical device plays a substantial role.

Up to now, in clinical trials with more then one site involved and with the requirement for using a medical device for data acquisition it is very likely that the medical devices are configured differently. They might be from the same or from different vendors. Representatives of the various sites - typically investigators and/or users of the medical devices (radiologists, etc.) get together and discuss about the required data for the clinical trial. In a next step they have to translate these requirements into configurations specific to their medical devices. This results in differences of the configurations. The data from the medical devices is comparable based on the experience and the judgement of the users of the medical devic...